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The Effect of Foot Massage on Pain, Sleep Quality and Early Discharge in Patients Undergoing Spinal Surgery

Primary Purpose

Spinal Fusion, Pain, Postoperative

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Foot Massage
Sponsored by
Istanbul Medeniyet University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Spinal Fusion focused on measuring Foot massage, Sleep quality, Spinal surgery, Postoperative pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Having TPF surgery,
  • Be over 18 years old,
  • No nerve damage or psychiatric disease in the history,
  • No central nervous system metastasis or disease,
  • No irritation or ulceration in the skin area to be massaged,
  • No history of deep vein thrombosis
  • To be able to speak and understand Turkish and to be able to read and write,
  • Patients with an ASA score of 1 and 2,
  • It is voluntary to participate in the research.

Exclusion Criteria:

  • Not wanting to leave the study for any reason,
  • Patients with an ASA score of 3 and above,
  • Complication development.

Sites / Locations

  • Sultan 2. Abdülhamid Han Training and Research HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Foot Massage

Control

Arm Description

Patients undergoing TPF surgery and foot massage

Those who underwent TPF surgery and did not receive foot massage

Outcomes

Primary Outcome Measures

Pain Visual Analogue Scale
The highest score that can be obtained from the visual analog scale is 10 and the lowest 0. As the higher score is obtained, the patient's pain will increase, and the result is evaluated as bad. Visual Analogue Scale scores will decrease after progressive muscle relaxation exercises. The highest score that can be obtained from the visual analog scale is 10 and the lowest 0. As the higher score is obtained, the patient's pain will increase, and the result is evaluated as bad. Visual Analogue Scale scores will decrease after progressive muscle relaxation exercises. The highest score that can be obtained from the visual analog scale is 10 and the lowest 0. As the higher score is obtained, the patient's pain will increase, and the result is evaluated as bad.
Sleep Richard-Campbell Sleep Questionnaire
A score of "0-25" from the scale indicates that the scale is very bad, and a score of "76-100" indicates that the scale is very good.

Secondary Outcome Measures

Full Information

First Posted
April 17, 2022
Last Updated
May 31, 2023
Sponsor
Istanbul Medeniyet University
Collaborators
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT05354830
Brief Title
The Effect of Foot Massage on Pain, Sleep Quality and Early Discharge in Patients Undergoing Spinal Surgery
Official Title
The Effect of Foot Massage on Pain, Sleep Quality and Early Discharge in Patients Undergoing Spinal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
June 1, 2023 (Actual)
Study Completion Date
October 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medeniyet University
Collaborators
Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
In recent years, it is known that the use of complementary approaches, which are accepted as a safe and effective method for maintaining health and well-being, providing relaxation/relaxation, and reducing the effects of illness, has been increasing. It is reported that massage, which originates from an instinctive need for touch and is one of the oldest treatment methods, was first described in China in the second century BC and immediately after in India and Egypt, and was widely used by other early cultures such as Arabs, Greeks, Italians and Romans. In papyruses, on rocks, and in ancient oral stories dating back 15,000 years, there is evidence of the use of hands to provide comfort and healing. It is stated that foot massage, which is one of the most frequently used massage types today, has been applied in different parts of the world such as Egypt, India and China for thousands of years. In addition to pharmacological methods, non-pharmacological complementary and alternative treatment methods are also used in the control of pain due to reasons such as dissatisfaction with traditional treatment methods, reluctance to use invasive procedures and daily analgesics, and the toxic effects of drugs. Massage provides relaxation both physically and mentally. It is thought to reduce edema by accelerating circulation, muscle tension and anxiety by the stimuli reaching the spinal cord, and pain sensation by stimulating peripheral sensory receptors.
Detailed Description
In recent years, it is known that the use of complementary approaches, which are accepted as a safe and effective method for maintaining health and well-being, providing relaxation/relaxation, and reducing the effects of illness, has been increasing. It is reported that massage, which originates from an instinctive need for touch and is one of the oldest treatment methods, was first described in China in the second century BC and immediately after in India and Egypt, and was widely used by other early cultures such as Arabs, Greeks, Italians and Romans. In papyruses, on rocks, and in ancient oral stories dating back 15,000 years, there is evidence of the use of hands to provide comfort and healing. It is stated that foot massage, which is one of the most commonly used types of massage today, has been applied in different parts of the world such as Egypt, India and China for thousands of years. It is stated that Ibn-i Sina talked about the benefits of massage and included this subject in the world-famous source of information, El Kanun Fi't Medicine. It is reported that massage therapy started to be applied in the USA in the mid-1800s and continued its development by using it for different purposes, while in England, nine nurses came together and founded the Massage Association in 1894. In Turkey, it is stated that massage was first applied in Gülhane Serriyat Hospital in 1909 by physical therapists for treatment purposes. Spinal stabilization and fusion techniques for various pathological conditions of the spine began in the 1990s and have now become a surgical standard. The main purpose of surgical treatment in spinal disorders; to correct spinal deformity, increase spinal fusion rates, provide neurological decompression, ensure normal stability, and facilitate rehabilitation by reducing pain following surgery. He has defined many surgical intervention methods for the spine, and these are roughly classified as anterior, posterior and lateral intervention methods. Among these methods, posterior intervention methods are used most frequently. Posterior spine stabilization; It is performed using transpedicular screw and posterior bone fusion. Surgical intervention in degenerative disc disease; It can be applied with open and percutaneous fixation techniques. Transpedicular fixation (TPF); It is one of the most effective surgical methods in the treatment of spinal instability in terms of providing anatomical reduction, stable fixation and early mobilization. It immobilizes the mobile segment of the spine by allowing adequate decompression of neural structures and ensuring bone fusion. Screws in transpedicular fixation surgery; It can be implanted at different levels of the spine such as the cervical, thoracic, lumbar and sacral regions. Pain is a part of the common experiences that people live most of the time, and it is a complex sensation that affects people, is affected by individual characteristics, is always subjective, subjective, and difficult to understand and define. Pain affects the life of the individual physically, mentally and socially and reduces the quality of life of individuals. Therefore, controlling the pain experienced by individuals is important in terms of relaxation of the individual, increasing the quality of life, reducing complications and shortening the length of hospital stay. Today, pharmacological methods are widely used in the control of pain. However, when analgesics are used unconsciously and intensively, they have a negative effect on some physiological functions; Especially in cases where narcotics are used, undesirable situations such as tolerance development due to increasing the dose are encountered each time. In addition to pharmacological methods, non-pharmacological complementary and alternative treatment methods are also used in the control of pain due to reasons such as dissatisfaction with traditional treatment methods, reluctance to use invasive procedures and daily analgesics, and the toxic effects of drugs. Massage provides relaxation both physically and mentally. It is thought that it reduces edema by accelerating circulation, muscle tension and anxiety when stimuli reach the spinal cord, and pain sensation by stimulating peripheral sensory receptors. As with every surgical procedure, intense postoperative pain occurs especially after spinal surgery. Many factors play a role in the emergence of this pain. One of these is the postoperative inflammatory tissue response. Another factor is the long-term use of automatic retractor systems placed on the paravertebral muscles during spinal surgery. Undesirable severe low back pain in the postoperative period due to prolonged paravertebral muscle retraction is a common and distressing condition for both the patient and the surgeon in the early postoperative period. Therefore, intensive and strong analgesic treatments and even narcotic analgesics have to be used in the early postoperative period. It is stated that pain increases the level of depression, this situation lowers the pain threshold and negatively affects sleep quality in pain and depression. Sleep disorders reduce the quality of life; It increases the risk of falling, the cost of treatment, and most importantly, the death rate in patients. Foot massage provides the transfer of sensory stimuli to the brain by stimulating the nervous system and increasing dopamine secretion. The advantages of foot massage are that it is easy to apply, inexpensive, and no special equipment is needed. Studies on pain and anxiety management with foot massage; shows that it is possible to reduce the pain of patients with this method.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Fusion, Pain, Postoperative
Keywords
Foot massage, Sleep quality, Spinal surgery, Postoperative pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled parallel groups
Masking
Investigator
Masking Description
It was planned as an open-label, blinded, randomized and controlled experimental study. A computer-assisted simple randomization method was used to distribute the groups homogeneously. For this purpose, 72 sets were created by using the functions available at the "https://www.random.org/integer-sets" internet address, and each of these sets included 8 participants, 4 participants from each study group. As the next operation, 72 sets were shown with 1 number each, and 9 numbers between 1 and 72 were generated using the "RANDOMLY SEARCH" function in Excel, and 9 sets to be used in randomization were randomly determined. In order to reach the sample number of 68 people, 4 participants, 2 from each study group, were selected in the final set. Thus, patients were randomly assigned to the experimental and control groups in order to reduce selection bias and control the variables that may affect the outcome parameters.
Allocation
Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Foot Massage
Arm Type
Experimental
Arm Description
Patients undergoing TPF surgery and foot massage
Arm Title
Control
Arm Type
No Intervention
Arm Description
Those who underwent TPF surgery and did not receive foot massage
Intervention Type
Other
Intervention Name(s)
Foot Massage
Intervention Description
Foot Massage
Primary Outcome Measure Information:
Title
Pain Visual Analogue Scale
Description
The highest score that can be obtained from the visual analog scale is 10 and the lowest 0. As the higher score is obtained, the patient's pain will increase, and the result is evaluated as bad. Visual Analogue Scale scores will decrease after progressive muscle relaxation exercises. The highest score that can be obtained from the visual analog scale is 10 and the lowest 0. As the higher score is obtained, the patient's pain will increase, and the result is evaluated as bad. Visual Analogue Scale scores will decrease after progressive muscle relaxation exercises. The highest score that can be obtained from the visual analog scale is 10 and the lowest 0. As the higher score is obtained, the patient's pain will increase, and the result is evaluated as bad.
Time Frame
12 months
Title
Sleep Richard-Campbell Sleep Questionnaire
Description
A score of "0-25" from the scale indicates that the scale is very bad, and a score of "76-100" indicates that the scale is very good.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Having TPF surgery, Be over 18 years old, No nerve damage or psychiatric disease in the history, No central nervous system metastasis or disease, No irritation or ulceration in the skin area to be massaged, No history of deep vein thrombosis To be able to speak and understand Turkish and to be able to read and write, Patients with an ASA score of 1 and 2, It is voluntary to participate in the research. Exclusion Criteria: Not wanting to leave the study for any reason, Patients with an ASA score of 3 and above, Complication development.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eda Polat, MSc
Phone
+905415660731
Email
edda_akyol@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Tuluha Ayoğlu, PhD
Phone
+905424849395
Email
tuluha@iuc.edu.tr
Facility Information:
Facility Name
Sultan 2. Abdülhamid Han Training and Research Hospital
City
Istanbul
State/Province
Üsküdar
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eda Polat, MSc
Phone
+905415660731
Email
edda_akyol@hotmail.com
First Name & Middle Initial & Last Name & Degree
Tuluha Ayoğlu, PhD
Phone
+905424849395
Email
tuluha@iuc.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The work will not be shared after publication.
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The Effect of Foot Massage on Pain, Sleep Quality and Early Discharge in Patients Undergoing Spinal Surgery

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